← Back to Search

Anti-infective agent

Clofazimine Inhalation for Nontuberculous Mycobacterial Infections (ICoN-1 Trial)

Phase 3

Recruiting

Research Sponsored by Mannkind Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be able to produce at least 3 mL of sputum or be willing to undergo an induction that produces at least 3 mL of sputum for mycobacteriology

Currently receiving a multi-drug regimen of GBT for pulmonary NTM infection in line with the 2020 ATS/ERS/ESCMID/IDSA guideline for the treatment of NTM pulmonary disease for at least 6 months prior to consenting in this study, with no changes in this regimen within 2 months of screening

Must not have

Prior therapy with clofazimine in the previous 4 months from date of screening

Prior therapy with amikacin by any route of administration in the previous 2 months from date of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of months 1,2,3,4,5, and 6

Awards & highlights

Pivotal Trial

Summary

This trial will compare whether Clofazimine Inhalation Suspension is better than a placebo when added to standard therapy for a specific condition in terms of effectiveness and safety.

Who is the study for?

Adults aged 18-85 with lung disease caused by Mycobacterium Avium Complex (MAC), who are already on a multi-drug regimen for at least 6 months, can produce sputum samples, and have no recent use of certain drugs or conditions like active cancer. Women must not be pregnant and agree to contraception; men must also agree to contraception if they can father children.

What is being tested?

The trial is testing the effectiveness and safety of Clofazimine Inhalation Suspension compared to a placebo in patients with MAC lung disease. Participants will continue their current drug regimens alongside the trial medication or placebo.

What are the potential side effects?

Potential side effects may include hypersensitivity reactions due to clofazimine's ingredients, as well as any common side effects associated with inhalation therapies such as coughing or throat irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can produce the required amount of sputum for the test.

Select...

I have been on a specific treatment for NTM lung infection for at least 6 months without changes.

Select...

I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not taken clofazimine in the last 4 months.

Select...

I have not taken amikacin in the last 2 months.

Select...

I have cystic fibrosis.

Select...

I have active tuberculosis.

Select...

I have a widespread MAC or MABSC infection.

Select...

My MAC infection is resistant to clofazimine.

Select...

My heart's electrical activity is irregular or too fast.

Select...

My family has a history of sudden or unexplained deaths related to heart issues.

Select...

I was in the ICU, with or without a breathing machine, in the last 3 months.

Select...

I have not taken bedaquiline in the last year.

Select...

My liver disease is in an advanced stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of months 1,2,3,4,5, and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of months 1,2,3,4,5, and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of months 1,2,3,4,5, and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(Part A) Change in QoL-B RSS from baseline to end of Month 6 (Part A)

(Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for NTM) by the end of Month 6

Secondary study objectives

(Part A) Change in 6-minute walk distance (6MWD) from baseline to the end of Month 6

(Part A) Change in participant identified Most Bothersome Symptom (MBS) from baseline to the end of Month 6

(Part A) Change in response to the Patient Global Impression of Severity (PGI-S) questionnaire from baseline to the end of Month 6

+2 more

Other study objectives

(Part A) All-cause mortality

(Part A) Change in BMI from baseline to the end of Month 6

(Part A) Change in forced expiratory volume in 1 second (FEV1) from baseline to the end of Month 6

+41 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Clofazimine Inhalation SuspensionExperimental Treatment1 Intervention

MNKD-101 (Clofazimine Inhalation Suspension) is a micronized suspension with a concentration of 20 mg/mL. Study drug will be inhaled using the PARI breath-enhanced jet nebulizer system daily for 28 days in Cycle 1. Cycle 2 will commence after 56 days off treatment and resume daily for 28 days. Dose: 80 mg

Group II: PlaceboPlacebo Group1 Intervention

The placebo is comprised of isotonic saline (0.9% weight/volume sodium chloride). Study drug will be inhaled using the PARI breath-enhanced jet nebulizer system daily for 28 days in Cycle 1. Cycle 2 will commence after 56 days off treatment and resume daily for 28 days.

0 / 14Eligibility criteria met